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Regulatory Focus™ > News Articles > 2020 > 7 > FDA Approvals Roundup: Tecartus, Breztri Aerosphere, Wynzora

FDA Approvals Roundup: Tecartus, Breztri Aerosphere, Wynzora

Posted 29 July 2020 | By Renee Matthews 

FDA Approvals Roundup: Tecartus, Breztri Aerosphere, Wynzora

A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).
 
New approvals
Tecartus okayed as first CAR-T therapy for MCL
Kite’s Tecartus (brexucabtagene autoleucel), a customized, one-time therapy derived from a patient’s genetically modified T cells, has received accelerated approval for treating adults with relapsed or refractory mantle cell lymphoma (MCL).
 
It is the first chimeric antigen receptor T-cell (CAR-T) therapy approved by the FDA for the treatment of MCL, a rare form of malignant B-cell non-Hodgkin lymphoma prevalent in older adults. The genetic modifications in the CAR-T therapy allow it to target and destroy the lymphoma cells after its infusion back into the patient.
 
“Tremendous progress has been made in the discovery of new therapies for debilitating diseases that are difficult to treat. This approval is yet another example of customized treatments that use a patient’s own immune system to help fight cancer,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research (CBER).
 
The drug’s safety and efficacy were established in ZUMA-2, a multicenter, single-arm, open-label clinical trial that enrolled 74 patients with previously treated refractory or relapsed MCL who received a single infusion of Tecartus. They were followed for at least 6 months after their first objective disease response. Of those patients, 87% had an objective response to the single infusion, and 62% achieved complete remission.
 
Tecartus has been approved with a risk evaluation and mitigation strategy (REMS), which includes elements to assure safe use, because it has a boxed warning for cytokine release syndrome and neurologic toxicity. Its REMS measures are the same as those for Yescarta (axicabtagene ciloleucel, another CAR-T therapy from the Kite stable, approved for treating large B-cell lymphoma.
 
Kite must also conduct a postmarketing, observational study of patients who receive Tecartus to evaluate its long-term safety.
 
Tecartus was granted priority review, breakthrough therapy, and orphan drug designations. The application was reviewed using a cross-agency approach, in which the agency’s Oncology Center of Excellence oversaw the clinical review and CBER conducted all other aspects of the review and made the final approval determination.
 
Breztri Aerosphere approved as maintenance therapy for COPD
AstraZeneca’s Breztri Aerosphere (budesonide, glycopyrrolate, and formoterol fumarate inhaler) has been approved as a maintenance therapy for patients with chronic obstructive pulmonary disease (COPD), a progressive, incurable disease in which airflow in the lungs is obstructed, causing debilitating breathlessness, known as exacerbations.
 
Approval of the triple-combination, long-action therapy was based on data from the phase 3 ETHOS trial showing a significant reduction in the rate of moderate or severe exacerbations, compared with dual-combination therapies, AstraZeneca’s Bevespi Aerosphere (glycopyrrolate/formoterol fumarate) and PT009 (budesonide/formoterol fumarate). Positive findings from the phase 3 KRONOS trial vouched for the therapy’s safety and efficacy.
 
“Preventing exacerbations is central to the management of chronic obstructive pulmonary disease. Even a single exacerbation can have a negative impact on a patient’s lung function and quality of life, and it can increase the risk of death. Breztri Aerosphere has demonstrated significant benefits in reducing exacerbations in patients suffering from COPD,” said Fernando J. Martinez, MD, chief of division of pulmonary and critical care medicine at Weill Cornell Medicine and New York-Presbyterian Weill Cornell Medical Center, New York, and an investigator in the ETHOS trial.
 
Breztri Aerosphere is already approved in Japan and China for patients with COPD and is under regulatory review in the European Union.
 
With the approval of Breztri Aerosphere, AstraZeneca must make a $150m milestone payment to Pearl Therapeutics, under a 2013 acquisition agreement between the two companies.
 
Wynzora Cream greenlighted for adults with plaque psoriasis
MC2 Therapeutics’ Wynzora Cream (calcipotriene and betamethasone dipropionate) has been approved as a once-daily, topical therapy for patients aged 18 years or older who have plaque psoriasis.
 
Wynzora’s safety and efficacy were evaluated in a phase 3, randomized, vehicle and active-comparator controlled trial in 794 adults with mild to moderate plaque psoriasis. Participants were randomized to treatment with Wynzora Cream, a vehicle cream, or Talconex (calcipotriene/betamethasone dipropionate topical suspension) and were assessed for treatment success after 8 weeks. Disease severity was determined by a Physician’s Global Assessment (PGA) scale.
 
At 8 weeks, there was a 14.3% difference in PGA treatment success between Wynzora and Talconex, in favor of Wynzora. At 4 weeks, more patients in the active ingredient group showed improvement in the peak pruritus numeric rating score than those in the vehicle cream group (60.3% vs. 21.4%, respectively).
 
Wynzora uses MC2’s proprietary oil-in-water dispersion vehicle technology.
 
Xeglyze nabs approval as head lice treatment
Dr. Reddy’s Xeglyze (abametapir lotion) has been given the go-ahead for the topical treatment of head lice infestation in patients aged 6 months or older.
 
Xeglyze’s approval was supported by findings from two identical multicenter, randomized, vehicle-controlled trials in 704 participants, aged 6 months to 49 years, with head lice infestation. They received a single, 10-minute application of Xeglyze or vehicle control and were assessed in follow-up visits on days 1, 7, and 14. Participants who presented with live lice at any of the follow-up visits were deemed treatment failures. For both trials, 81% of participants treated with Xeglyze were free of lice through all visits, compared with 51% of the vehicle controls in one trial, and 47% in the second.
 
Following the approval, Dr. Reddy’s must make a $20 million milestone payment to Hatchtech, under a 2015 commercialization deal between the two companies.
 

Tags: FDA, US

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